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Morcellator


Power Morcellator 
Kershaw, Cook & Talley is investigating a medical device known as the Laparoscopic Uterine Power Morcellator. Laparoscopic power morcellators are used during various laparoscopic (minimally invasive) surgeries or procedures to remove the uterus (hysterectomies), and treat or remove uterine fibroids (myomectomy). Fibroids are noncancerous uterine growths. Morcellation is essentially cutting up or grinding the affected tissue into smaller pieces in order to remove the tissue via an incision site. The Food and Drug Administration (FDA) began approving the laparoscopic power morcellators in 1995.

On April 17, 2014, nearly two decades after the device was approved, the FDA released a safety communication warning health care professionals against using the power morcellators to treat uterine fibroids. In an updated safety communication, released November 24, 2014, the FDA stated, “When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus” (FDA News Release). The FDA announced the risk of morcellating an unsuspected uterine sarcoma is 1 in 352 and the risk of morcellating an unsuspected uterine leiomyosarcoma (malignant uterine tumor) is 1 in 498. This poses a significant health threat because the procedure spreads the cancer into the abdomen and pelvis, consequently decreasing and worsening the long-term survival of patients.


Morcellator Timeline

May 25, 1995: The FDA approves the first laparoscopic power morcellator. To date, the agency has approved approximately 2 dozen.

November 2009:  The American College of Obstetricians and Gynecologists (ACOG) releases committee opinion article stating, “Evidence demonstrates that, in general, vaginal hysterectomy is associated with better outcomes and fewer complications than laparoscopic or abdominal hysterectomy.”

November 26, 2012: Peritoneal Dissemination Complicating Morcellation of Uterine Mesenchymal Neoplasms discusses “When morcellated uterine tumors are unexpectedly found to be leiomyosarcomas or tumors with atypical features (atypical leiomyoma, smooth muscle tumor of uncertain malignant potential), there may be significant clinical consequences.”

March 2013: NIH releases facts sheet on uterine fibroids. 

December 2013: The Society of Gynecologic Oncology (SGO) states morcellation is contraindicated for women with pre-malignant conditions.

July 2014: FDA convenes a meeting of the Obstetrics and Gynecological Medical Device Advisory Panel. The panel discussed patient populations in which laparoscopic power morcellators should not be used, mentioning specifically patients with known or suspected malignancy.

April 17, 2014: FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids in safety communication.

November 24, 2014: The agency updates previous safety warning and estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma.


Free Case Evaluation

Most of our cases involve women with leiomyosarcoma. If you have uterine cancer or abdominal cancer from morcellation, we recommend you contact us immediately. We will investigate if the Laparoscopic Uterine Power Morcellator was used in your surgery and subsequently lead to your cancer. You may have a claim against the manufacturer. If you have any questions, contact us for a free case evaluation. You can call us toll-free at (888) 997-51570, or fill out and submit the contact form found on this page.

Contact Us

DISCLAIMER:

By sending this email information to Kershaw, Cook & Talley, an attorney-client relationship is not created between you and Kershaw, Cook & Talley, or any other party. An attorney-client relationship does not exist until a formal “Attorney Retainer/Fee Agreement” has been signed by all parties.

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